Information for Users (Labeling/IFU) • Labeling requirements (23.2) • Label must have indication if the device incorporates: • Medicinal substance • Human blood/plasma derivative • Tissues/cells/derivatives of human origin • Tissues/cells/derivatives of animal origin • Indication if carcinogenic/mutagenic/toxic (CMR) substances
Instructions for Use (IFU) are a type of FDA-approved patient labeling for drugs that have complicated or detailed patient-use instructions.
Patient Labeling Resources - FDA
Aug 19, 2024 · The Instructions for Use (IFU) is patient labeling that can be part of FDA-approved prescription drug labeling for a biologics license application (BLA), a new drug application (NDA), or an...
The IFU guides the patient on how to safely and effectively use a prescription drug product and commonly includes instructions on preparation, administration, handling, storage, and disposal.
Manufacturers Instructions for Use - The Joint Commission
Oct 21, 2021 · These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device.
Labelling of Medical Devices and Instrictions for Use (IFU)
Sep 23, 2016 · All medical devices are expected to be supplied with appropriate instructions for use (IFU). Medsafe recognises the trend towards supply of instructions for use in electronic formats and has guidance regarding electronic IFU.
Instructions for use: patient labeling for human prescription drug …
This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).
Dec 11, 2024 · General requirements for identification and labels on: - medical device or accessory - packaging - marking of a medical device or accessory - accompanying information (EU) eIFU 2021/2226. electronic instructions for use of medical devices. IEC 62366- 1. IFU must be developed following a usability engineering process following 62366 -1. IEC 60601 -1
IFU for Medical Devices, a Definitive Guide (EU & US) - INSTRKTIV
Read all information on creating instructions for use or IFU for medical devices for the EU & US to comply with (EU) 2017/745 and FDA requirements here.
IFU Labeling for iFuse - SI-BONE
SI-BONE is the developer of the iFuse Implant System, a minimally invasive surgical treatment for sacroiliac joint disorders. Learn about SI joint disorders.